Company focused on obtaining approval for outpatient (at-home) use of IGALMI® for the acute treatment of agitation associated ...

Marty Makary, commissioner of the FDA, is naming George Tidmarsh director of the Center for Drug Evaluation and Research.

2025年7月3日，迪哲医药（股票代码：688192.SH）宣布，舒沃哲（ZEGFROVY，通用名：舒沃替尼片）的新药上市申请（New Drug ...

The Food and Drug Administration said it has appointed former biotech executive George Tidmarsh as the agency's top drug ...

36氪获悉，迪哲医药公告，公司自主研发的舒沃哲®的新药上市申请（New Drug Application，NDA），正式获得美国食品药品监督管理局批准，用于既往经含铂化疗治疗时或治疗后出现疾病进展，并且经FDA批准的试剂盒检测确认，存在表皮生长因子受体（EGFR）20号外显子插入突变（Exon20ins）的局部晚期或转移性非小细胞肺癌（NSCLC）的成人患者。

经济观察网讯 据迪哲Dizal微信公众号7月3日消息，迪哲医药（股票代码：688192.SH）宣布，舒沃哲®（ZEGFROVY®，通用名：舒沃替尼片）的新药上市申请（New Drug Application，NDA），正式获得美国食品药品监督管理局（FDA）批准，用于既往经含铂化疗治疗时或治疗后出现疾病进展，并且经FDA批准的试剂盒检测确认，存在表皮生长因子受体（EGFR）20号外显子插入突变（e ...

An FDA advisory panel will meet July 18 to consider a supplemental new drug application for the antipsychotic brexpiprazole, ...

The new drug application is supported by 48-week data from the Phase III MK-8591A-051 and MK-8591A-052 trials, which showed ...

The FDA accepted Aldeyra's resubmitted NDA for reproxalap after previous rejections due to efficacy concerns, despite no ...

President Donald Trump's proposed budget cuts to the National Institutes of Health would eventually result in fewer drugs on ...

Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of ...

The Investigational New Drug (IND) process was established to ensure that the FDA is informed of any new treatment before use in humans. The process is now used for approval rather than notification.